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The HS-RISE study aims to assess real-world HS treatment outcomes and patterns, safety of secukinumab, and to describe the baseline characteristics of patients diagnosed with moderate-to- severe HS who are prescribed secukinumab in Canadian routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Patients with moderate-to-severe HS who are prescribed secukinumab in Canadian routine clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who experience a change in disease severity classification | Proportion of patients who experience a change in disease severity classification from baseline to 12 months, as determined by the International HS Severity Score System (IHS4). Determining IHS4 score requires counting nodules, abscesses and draining tunnels/sinus tracts. A score of 3 or less signifies mild HS, a score of 4 to 10 signifies moderate HS, and a score of 11 or higher signifies severe HS. | Baseline, month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients overall who experience a change in disease severity classification | Proportion of patients overall who experience a change in disease severity classification as determined by IHS4 from baseline at Months 3 and 6; additional subgroups analyses by ethnicity/race. Determining IHS4 score requires counting nodules, abscesses and draining tunnels/sinus tracts. A score of 3 or less signifies mild HS, a score of 4 to 10 signifies moderate HS, and a score of 11 or higher signifies severe HS. |
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Inclusion Criteria:
Exclusion Criteria:
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Canadian patients diagnosed with moderate-to-severe HS and treated with secukinumab as per routine clinical practice
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | novartis.email@novartis.com |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Calgary | Alberta | T2J 7E1 | Canada | |
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Baseline, Month 3, Month 6 |
| Proportion of patients achieving a 55% reduction in International HS Severity Score System (IHS4-55) | Proportion of patients achieving IHS4-55 at Months 3, 6, and 12; additional subgroups analyses by ethnicity/race. IHS4-55 is defined as at least a 55% reduction in their IHS4 from baseline. | Baseline, Month 3, Month 6, Month 12 |
| Proportion of patients experiencing HS Clinical Response 50 (HiSCRO50) | Proportion of patients achieving a 50% reduction from baseline in HS Clinical Response Score (HiSCR50) at Months 3, 6, and 12; additional subgroups analyses by ethnicity/race. HiSCR50 is defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscesses or draining fistulae count. | Baseline, Month 3, Month 6, Month 12 |
| Mean reduction in abscess and inflammatory nodule count | Mean reduction in abscess and inflammatory nodule count from baseline at Months 3, 6, and 12; additional subgroups analyses by ethnicity/race | Baseline, Month 3, Month 6, Month 12 |
| Descriptive summaries of demographic and clinical variables | Descriptive summaries demographic and clinical variables | Baseline |
| Proportion of patients receiving secukinumab up-titration from every 4 weeks (Q4W) to every 2 weeks (Q2W) | Proportion of patients receiving secukinumab up-titration from Q4W to Q2W at Months 3, 6, and 12; Subgroup analysis by ethnicity/race as well as time to biologic treatment initiation | Month 3, Month 6, Month 12 |
| Proportion of patients receiving secukinumab down-titration from every 2 weeks (Q2W) to every 4 weeks (Q4W) | Proportion of patients receiving secukinumab down-titration from Q2W to Q4W at Months 3, 6, and 12; Subgroup analysis by ethnicity/race as well as time to biologic treatment initiation | Month 3, Month 6, Month 12 |
| Time to secukinumab up- and down-titration | Time to secukinumab up- and down-titration | Month 3, Month 6, Month 12 |
| Proportion of patients experiencing adverse events post-secukinumab initiation | Proportion of patients experiencing adverse events post-secukinumab initiation | Up to 12 Months |
| Proportion of patients experiencing serious adverse events post-secukinumab initiation | Proportion of patients experiencing serious adverse events post-secukinumab initiation | Up to 12 Months |
| Type of adverse events and serious adverse events experienced by patients post-secukinumab initiation | Type of adverse events and serious adverse events experienced by patients post-secukinumab initiation | Up to 12 Months |
| Proportion of patients who discontinued secukinumab due to adverse events | Proportion of patients who discontinued secukinumab due to adverse events | Up to 12 Months |
| Proportion of patients receiving additional HS-related therapies | Proportion of patients receiving additional HS-related therapies at Months 3, 6, and 12; additional subgroup analysis by dosing, ethnicity/race and time to biologic initiation | Month 3, Month 6, Month 12 |
| Proportion of patients requiring unplanned surgeries | Proportion of patients requiring unplanned surgeries at Month 3, 6, and 12; additional subgroup analysis by dosing, ethnicity/race and time to biologic initiation | Month 3, Month 6, Month 12 |
| Proportion of patients discontinuing secukinumab treatment | Proportion of patients discontinuing secukinumab treatment at Months 3, 6, and 12; additional sugbroup analyses also done by ethnicity/race | Month 3, Month 6, Month 12 |
| Reason(s) for secukinumab discontinuation | Reason(s) for secukinumab discontinuation; additional subgroup analyses by ethnicity/race | Up to 12 Months |
| Percentage of no-show appointments which were scheduled as per standard of care | Percentage of no-show appointments which were scheduled as per standard of care with participating dermatologist (including injections) and the corresponding reason(s); additional subgroup analyses by ethnicity/race | Up to 12 Months |
| Recruiting |
| Calgary |
| Alberta |
| T3E 0B2 |
| Canada |
| Novartis Investigative Site | Recruiting | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Novartis Investigative Site | Recruiting | Fredericton | New Brunswick | E3B 1G9 | Canada |
| Novartis Investigative Site | Recruiting | St. John's | Newfoundland and Labrador | A1E 1V4 | Canada |
| Novartis Investigative Site | Recruiting | Cobourg | Ontario | K9A 4J9 | Canada |
| Novartis Investigative Site | Recruiting | Hamilton | Ontario | L8P4B4 | Canada |
| Novartis Investigative Site | Recruiting | London | Ontario | N6H 5L5 | Canada |
| Novartis Investigative Site | Recruiting | Markham | Ontario | L3P 1X3 | Canada |
| Novartis Investigative Site | Recruiting | Mississauga | Ontario | L4W 0C2 | Canada |
| Novartis Investigative Site | Recruiting | Richmond Hill | Ontario | L4C 9M7 | Canada |
| Novartis Investigative Site | Recruiting | Toronto | Ontario | M4E 1R7 | Canada |
| Novartis Investigative Site | Recruiting | Saint-Jérôme | Quebec | J7Z 7E2 | Canada |
| Novartis Investigative Site | Recruiting | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Novartis Investigative Site | Recruiting | Saskatoon | Saskatchewan | S7N0N5 | Canada |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |